Apparatus and method for manipulating stomach tissue and treating gastroesophageal reflux disease

ABSTRACT

Stomach tissue is manipulated to form, for example, a restored flap of a gastroesophageal flap valve. The manipulation includes gripping stomach tissue from within the stomach while the stomach is inflated to promote visualization and stabilization of the gripped stomach tissue. Once the stomach tissue is gripped, the stomach is deflated and pulled into a mold. The molded tissue is then fastened with at least one fastener. The stomach is inflated to a first pressure during visualization and then to a second higher pressure during the stomach tissue gripping.

This application is a continuation of U.S. application Ser. No.12/975,346, filed on Dec. 21, 2010, which is a continuation of U.S.application Ser. No. 11/172,427, filed on Jun. 29, 2005 (now abandoned).The entire disclosures of which are hereby incorporated by reference forall purposes.

FIELD OF THE INVENTION

The present invention generally relates to manipulation of stomachtissue as by folding, molding, and/or fastening and to treatinggastroesophageal reflux disease using such techniques. The presentinvention more particularly relates to locating tissue fixation devicesfor fixing stomach tissue to stomach tissue in surgical environments topromote reliable fixating of stomach tissue.

BACKGROUND

Gastroesophageal reflux disease (GERD) is a chronic condition caused bythe failure of the anti-reflux barrier located at the gastroesophagealjunction to keep the contents of the stomach from splashing into theesophagus. The splashing is known as gastroesophageal reflux. Thestomach acid is designed to digest meat, and will digest esophagealtissue when persistently splashed into the esophagus.

A principal reason for regurgitation associated with GERD is themechanical failure of a deteriorated gastroesophageal flap to close andseal against high pressure in the stomach. Due to reasons includinglifestyle, a Grade I normal gastroesophageal flap may deteriorate into amalfunctioning Grade III or absent valve Grade IV gastroesophageal flap.With a deteriorated gastroesophageal flap, the stomach contents are morelikely to be regurgitated into the esophagus, the mouth, and even thelungs. The regurgitation is referred to as “heartburn” because the mostcommon symptom is a burning discomfort in the chest under thebreastbone. Burning discomfort in the chest and regurgitation (burpingup) of sour-tasting gastric juice into the mouth are classic symptoms ofgastroesophageal reflux disease (GERD). When stomach acid isregurgitated into the esophagus, it is usually cleared quickly byesophageal contractions. Heartburn (backwashing of stomach acid and bileonto the esophagus) results when stomach acid is frequently regurgitatedinto the esophagus and the esophageal wall is inflamed.

Complications develop for some people who have GERD. Esophagitis(inflammation of the esophagus) with erosions and ulcerations (breaks inthe lining of the esophagus) can occur from repeated and prolonged acidexposure. If these breaks are deep, bleeding or scarring of theesophagus with formation of a stricture (narrowing of the esophagus) canoccur. If the esophagus narrows significantly, then food sticks in theesophagus and the symptom is known as dysphagia. GERD has been shown tobe one of the most important risk factors for the development ofesophageal adenocarcinoma. In a subset of people who have severe GERD,if acid exposure continues, the injured squamous lining is replaced by aprecancerous lining (called Barrett's Esophagus) in which a cancerousesophageal adenocarcinoma can develop.

Other complications of GERD may not appear to be related to esophagealdisease at all. Some people with GERD may develop recurrent pneumonia(lung infection), asthma (wheezing), or a chronic cough from acidbacking up into the esophagus and all the way up through the upperesophageal sphincter into the lungs. In many instances, this occurs atnight, while the person is in a supine position and sleeping.Occasionally, a person with severe GERD will be awakened from sleep witha choking sensation. Hoarseness can also occur due to acid reaching thevocal cords, causing a chronic inflammation or injury.

GERD never improves without intervention. Life style changes combinedwith both medical and surgical treatments exist for GERD. Medicaltherapies include antacids and proton pump inhibitors. However, themedical therapies only mask the reflux. Patients still get reflux andperhaps emphysema because of particles refluxed into the lungs.Barrett's esophagus results in about 10% of the GERD cases. Theesophageal epithelium changes into tissue that tends to become cancerousfrom repeated acid washing despite the medication.

Several open laparotomy and laparoscopic surgical procedures areavailable for treating GERD. One surgical approach is the Nissenfundoplication. The Nissen approach typically involves a 360-degree wrapof the fundus around the gastroesophageal junction. The procedure has ahigh incidence of postoperative complications. The Nissen approachcreates a 360-degree moveable flap without a fixed portion. Hence,Nissen does not restore the normal movable flap. The patient cannot burpbecause the fundus was used to make the repair, and may frequentlyexperience dysphagia. Another surgical approach to treating GERD is theBelsey Mark IV (Belsey) fundoplication. The Belsey procedure involvescreating a valve by suturing a portion of the stomach to an anteriorsurface of the esophagus. It reduces some of the postoperativecomplications encountered with the Nissen fundoplication, but still doesnot restore the normal movable flap. None of these procedures fullyrestores the normal anatomical anatomy or produces a normallyfunctioning gastroesophageal junction. Another surgical approach is theHill repair. In the Hill repair, the gastroesophageal junction isanchored to the posterior abdominal areas, and a 180-degree valve iscreated by a system of sutures. The Hill procedure restores the moveableflap, the cardiac notch and the Angle of His. However, all of thesesurgical procedures are very invasive, regardless of whether done as alaparoscopic or an open procedure.

New, less surgically invasive approaches to treating GERD involvetransoral endoscopic procedures. One procedure contemplates a machinedevice with robotic arms that is inserted transorally into the stomach.While observing through an endoscope, an endoscopist guides the machinewithin the stomach to engage a portion of the fundus with acorkscrew-like device on one arm. The arm then pulls on the engagedportion to create a fold of tissue or radial plication at thegastroesophageal junction. Another arm of the machine pinches the excesstissue together and fastens the excess tissue with one pre-tied implant.This procedure does not restore normal anatomy. The fold created doesnot have anything in common with a valve. In fact, the direction of theradial fold prevents the fold or plication from acting as a flap of avalve.

Another transoral procedure contemplates making a fold of fundus tissuenear the deteriorated gastroesophageal flap to recreate the loweresophageal sphincter (LES). The procedure requires placing multipleU-shaped tissue clips around the folded fundus to hold it in shape andin place.

This and the previously discussed procedure are both highly dependent onthe skill, experience, aggressiveness, and courage of the endoscopist.In addition, these and other procedures may involve esophageal tissue inthe repair. Esophageal tissue is fragile and weak, in part due to thefact, that the esophagus is not covered by serosa, a layer of verysturdy, yet very thin tissue, covering and stabilizing allintraabdominal organs, similar like a fascia covering and stabilizingmuscle. Involvement of esophageal tissue in the repair of agastroesophageal flap valve poses unnecessary risks to the patient, suchas an increased risk of fistulas between the esophagus and the stomach.

A new and improved apparatus and method for restoration of agastroesophageal flap valve is fully disclosed in U.S. Pat. No.6,790,214, issued Sep. 14, 2004, is assigned to the assignee of thisinvention, and is incorporated herein by reference. That apparatus andmethod provides a transoral endoscopic gastroesophageal flap valverestoration. A longitudinal member arranged for transoral placement intoa stomach carries a tissue shaper that non-invasively grips and shapesstomach tissue. A tissue fixation device is then deployed to maintainthe shaped stomach tissue in a shape approximating a gastroesophagealflap.

Whenever tissue is to be maintained in a shape as, for example, in theimproved assembly last mentioned above, it is necessary to first gripstomach tissue and then fasten at least two layers of gripped tissuetogether. In applications such as gastroesophageal flap valverestoration, it is desirable to grip stomach tissue displaced from theesophageal opening into the stomach so that when the stomach tissue ispulled aborally to form a flap, the flap will have sufficient length tocover the opening and function as a flap valve. With thegastroesophageal anatomy thus restored, the GERD will be effectivelytreated.

Locating the proper gripping point in the stomach is not a simplematter. When the stomach is empty, it is normally in a collapsed state.Visualization within the stomach is extremely difficult. Once a desiredgripping point is found, it is then necessary to form the GEFV flap andmaintain its shape without involving the esophageal tissue. Stillfurther, these manipulations of the stomach tissue must be repeated manytimes about the esophageal/stomach opening. Such further manipulationmust repeat the dimensions of the manipulated stomach tissue to resultin a valve structure of uniform geometry. This is, of course, extremelydifficult under the circumstances provided by the anatomy of thestomach.

In maintaining the shape of the manipulated stomach tissue, fastenersmay be employed. However, care must be taken against inadvertentlyfixing esophageal tissue to stomach tissue. As previously mentioned,this is fraught with potential complications.

Still further, the mere act of gripping stomach tissue may beproblematic. For example, one way stomach tissue may be gripped is snareit with a helical coil. In doing so, the helical coil is screwed intothe tissue. Unfortunately, the mere act of turning the coil can causethe stomach tissue to also rotate and “ball-up” about the helix. Such anevent greatly complicates the therapeutic procedure.

Hence, there is a need in the art for techniques and devices whichenable more ready manipulation of stomach tissue from within thestomach. The present invention addresses these and other issues.

SUMMARY

The invention provides a method of restoring a flap of agastroesophageal flap valve associated with a stomach. The methodcomprises inflating the stomach, gripping stomach tissue from within thestomach at a point displaced from the esophageal opening of the stomach,and deflating the stomach. The method further comprises pulling thegripped stomach tissue into a mold to form molded tissue, and deployingat least one fastener through the molded tissue.

The method may further comprise gripping a wall of the esophagus priorto gripping the stomach. The step of gripping a wall of the esophagusmay include gripping the wall of the esophagus with a vacuum.

The method may further comprise reinflating the stomach before deployingthe at least one fastener. The inflating step may include inflating thestomach to a first pressure. The method may further comprise visualizingthe stomach from within the stomach after inflating the stomach to thefirst pressure, and increasing inflation pressure within the stomach toa second pressure after visualizing the stomach before gripping stomachtissue.

The invention further provides a method of restoring a flap of agastroesophageal flap valve associated with a stomach, comprisinggripping stomach tissue from within the stomach at a point displacedfrom the esophageal opening of the stomach and collapsing the stomach.The method further comprises pulling the gripped stomach tissue into amold to form folded flap of tissue and deploying at least one fastenerthrough the folded flap of tissue.

The gripping, collapsing, pulling, and deploying steps may be repeatedfor forming another folded flap of tissue. Another fastener displacedfrom the at least one fastener may be deployed. The method may furthercomprise inflating the stomach before deploying the at least onefastener.

The method may further comprise inflating the stomach before grippingthe stomach tissue. The method may then comprise the further step ofre-inflating the stomach prior to deploying the at least one fastener.

Before the gripping step, the stomach may be inflated to a firstpressure. This may be followed by visualizing the stomach from withinthe stomach, and inflating the stomach to a second pressure. The secondpressure may be greater than the first pressure. The method may furthercomprise repeating the inflating, gripping, collapsing, pulling, anddeploying steps for forming another folded flap of tissue and deployingat least one other fastener displaced from the at least one fastener.The method may further comprise measuring from the folded flap of tissueprior to repeating the gripping step.

The invention still further provides a method of gripping stomach tissuefrom within a stomach. The method comprises visualizing the stomach fromwithin the stomach to determine a gripping location, inflating thestomach, and gripping the stomach at the gripping location while thestomach is inflated.

The invention still further provides an assembly for restoring agastroesophageal flap valve associated with a stomach. The assemblycomprises an elongated member having a distal end for placement in thestomach, and a gastroesophageal flap valve restoration device. Thedevice includes a chassis and a bail carried at the elongated memberdistal end. The chassis has a proximal end connected to the elongatedmember distal end and a distal end hingedly coupled to the bail. Thechassis and bail are arranged to mold stomach tissue there between. Thechassis further includes a window that permits gastroesophageal anatomyvisualization.

The window is at the proximal end of the chassis. The device may furthercomprise a passage that slidingly receives an endoscope adjacent thewindow.

The device may further include a fastener deployment guide having apredetermined orientation relative to the window. The fastenerdeployment guide may comprise at least one guide lumen.

The window may include a location marker. The device may further includea fastener deployment guide that guides a fastener into molded tissue.The deployment guide may have a predetermined orientation relative tothe location marker. A fastener deployer may then deploy a fastener inmolded tissue at a predetermined location relative to the locationmarker.

The invention still further provides a method of deploying a fastenerthrough stomach tissue a predetermined distance from a gastroesophagealjunction. The method comprises providing a fastener deployment apparatusincluding a window permitting visualization of gastroesophageal anatomywhen placed in an esophagus, a location marker viewable in the window,and a fastener deployer that ejects a fastener for deployment at apredetermined location relative to the location marker. The methodfurther comprises feeding the apparatus down the esophagus, aligning thelocation marker with respect to the gastroesophageal junction to causethe fastener deployer to be aboral of the gastroesophageal junction, andejecting a fastener from the fastener deployer with the location markeraligned with respect to the gastroesophageal junction.

The invention further provides a fastener deployment apparatus thatdeploys a fastener in body tissue. The apparatus comprises a windowpermitting visualization of internal body anatomy when placed in a body,a location marker viewable in the window, and a fastener deployer havinga predetermined orientation relative to the location marker that ejectsa fastener for deployment at a predetermined location relative to thelocation marker.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like reference numerals identify like elements, and wherein:

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract from a lower portion of the esophagusto the duodenum;

FIG. 2 is a front cross-sectional view of theesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap of the gastroesophageal flap valve (in dashedlines) and a Grade III reflux appearance gastroesophageal flap of thegastroesophageal flap valve (in solid lines);

FIG. 3 is a side view of an apparatus for restoring the flap of a GEFVaccording to an embodiment of the invention;

FIG. 4 is a simplified side view of an apparatus according to anembodiment of the invention being fed down an esophageal passage of apatient;

FIG. 5 is a side view, partly in cross-section, of a device according toan embodiment of the invention after having been initially fed into astomach to initiate a GERD treatment procedure according to anembodiment of the invention;

FIG. 6 is a view similar to FIG. 5 showing the device and stomach afterthe stomach has been inflated to a first pressure;

FIG. 7 is a view similar to FIG. 5 showing the device and stomach at afurther stage of the procedure;

FIG. 8 is a view similar to FIG. 5 showing the device centered andgripping the esophagus;

FIG. 9 is a view similar to FIG. 5 showing the device initially grippingthe stomach tissue after the stomach has been reinflated to a second,higher pressure;

FIG. 10 is a view similar to FIG. 5 showing the stomach partiallydeflated and gripped stomach tissue being pulled aborally towards thedevice;

FIG. 11 is a view similar to FIG. 5 showing the gripped stomach tissuebeing pulled to almost within the device;

FIG. 12 is a view similar to FIG. 5 showing the gripped stomach tissuewith the device, being molded, and ready to receive a fastener;

FIG. 13 is a view similar to FIG. 5 showing the molded stomach tissueafter receiving a fastener;

FIG. 14 is a perspective view illustrating a manner in which the deviceof FIGS. 3-13 may deploy a fastener through gripped stomach tissuelayers; and

FIG. 15 is a perspective view showing a fastener fully deployed.

DETAILED DESCRIPTION

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract 40 from a lower portion of theesophagus 41 to the duodenum 42. The stomach 43 is characterized by thegreater curvature 44 on the anatomical left side and the lessercurvature 45 on the anatomical right side. The tissue of the outersurfaces of those curvatures is referred to in the art as serosa tissue.As will be seen subsequently, the nature of the serosa tissue is used toadvantage for its ability to bond to like serosa tissue.

The fundus 46 of the greater curvature 44 forms the superior portion ofthe stomach 43, and traps gas and air bubbles for burping. Theesophageal tract 41 enters the stomach 43 at an esophageal orifice belowthe superior portion of the fundus 46, forming a cardiac notch 47 and anacute angle with respect to the fundus 46 known as the Angle of His 57.The lower esophageal sphincter (LES) 48 is a discriminating sphincterable to distinguish between burping gas, liquids, and solids, and worksin conjunction with the fundus 46 to burp. The gastroesophageal flapvalve (GEFV) 49 includes a moveable portion and an opposing morestationary portion.

The moveable portion of the GEFV 49 is an approximately 180 degree,semicircular, gastroesophageal flap 50 (alternatively referred to as a“normal moveable flap” or “moveable flap”) formed of tissue at theintersection between the esophagus 41 and the stomach 43. The opposingmore stationary portion of the GEFV 49 comprises a portion of the lessercurvature 45 of the stomach 43 adjacent to its junction with theesophagus 41. The gastroesophageal flap 50 of the GEFV 49 principallycomprises tissue adjacent to the fundus 46 portion of the stomach 43. Itis about 4 to 5 cm long (51) at it longest portion, and its length maytaper at its anterior and posterior ends.

The gastroesophageal flap 50 is partially held against the lessercurvature 45 portion of the stomach 43 by the pressure differentialbetween the stomach 43 and the thorax, and partially by the resiliencyand the anatomical structure of the GEFV 49, thus providing the valvingfunction. The GEFV 49 is similar to a flutter valve, with thegastroesophageal flap 50 being flexible and closeable against the othermore stationary side.

The esophageal tract is controlled by an upper esophageal sphincter(UES)in the neck near the mouth for swallowing, and by the LES 48 andthe GEFV 49 at the stomach. The normal anti-reflux barrier is primarilyformed by the LES 48 and the GEFV 49 acting in concert to allow food andliquid to enter the stomach, and to considerably resist reflux ofstomach contents into the esophagus 41 past the gastroesophageal tissuejunction 52. Tissue aboral of the gastroesophageal tissue junction 52 isgenerally considered part of the stomach because the tissue protectedfrom stomach acid by its own protective mechanisms. Tissue oral of thegastroesophageal junction 52 is generally considered part of theesophagus and it is not protected from injury by prolonged exposure tostomach acid. At the gastroesophageal junction 52, the juncture of thestomach and esophageal tissues form a zigzag line, which is sometimesreferred to as the “Z-line.” For the purposes of these specifications,including the claims, “stomach” means the tissue aboral of thegastroesophageal junction 52.

FIG. 2 is a front cross-sectional view of anesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap 50 of the GEFV 49 (shown in dashed lines) and adeteriorated Grade III gastroesophageal flap 55 of the GEFV 49 (shown insolid lines). As previously mentioned, a principal reason forregurgitation associated with GERD is the mechanical failure of thedeteriorated (or reflux appearance) gastroesophageal flap 55 of the GEFV49 to close and seal against the higher pressure in the stomach. Due toreasons including lifestyle, a Grade I normal gastroesophageal flap 50of the GEFV 49 may deteriorate into a Grade III deterioratedgastroesophageal flap 55. The anatomical results of the deteriorationinclude moving a portion of the esophagus 41 that includes thegastroesophageal junction 52 and LES 48 toward the mouth, straighteningof the cardiac notch 47, and increasing the Angle of His 57. Thiseffectively reshapes the anatomy aboral of the gastroesophageal junction52 and forms a flattened fundus 56.

The deteriorated gastroesophageal flap 55 shown in FIG. 2 has agastroesophageal flap valve 49 and cardiac notch 47 that are bothsignificantly degraded. Dr. Hill and colleagues developed a gradingsystem to describe the appearance of the GEFV and the likelihood that apatient will experience chronic acid reflux. L. D. Hill, et al., Thegastroesophageal flap valve: in vitro and in vivo observations,Gastrointestinal Endoscopy 1996:44:541-547. Under Dr. Hill's gradingsystem, the normal movable flap 50 of the GEFV 49 illustrates a Grade Iflap valve that is the least likely to experience reflux. Thedeteriorated gastroesophageal flap 55 of the GEFV 49 illustrates a GradeIII (almost Grade IV) flap valve. A Grade IV flap valve is the mostlikely to experience reflux. Grades II and III reflect intermediategrades of deterioration and, as in the case of III, a high likelihood ofexperiencing reflux. With the deteriorated GEFV represented bydeteriorated gastroesophageal flap 55 and the fundus 46 moved inferior,the stomach contents are presented a funnel-like opening directing thecontents into the esophagus 41 and the greatest likelihood ofexperiencing reflux. Disclosed subsequently is a device, assembly, andmethod which may be employed to advantage according to an embodiment ofthe invention in restoring the normal gastroesophageal flap valveanatomy.

Referring now to FIG. 3, it shows a device 100 according to anembodiment of the present invention. The device 100 includes alongitudinal member 102 for transoral placement of the device 100 intothe stomach. The device further includes a first member 104, hereinafterreferred to as the chassis, and a second member 106, hereinafterreferred to as the bail. The chassis 104 and bail are hingedly coupledat 107. The chassis 104 and bail 106 form a tissue shaper which, asdescribed subsequently in accordance with this embodiment of the presentinvention, shapes tissue of the stomach into the flap of a restoredgastroesophageal flap valve. The chassis 104 and bail 106 are carried atthe distal end of the longitudinal member 102 for placement in thestomach.

The device 100 has a longitudinal passage 101 to permit an endoscope 110to be guided through the device and into the stomach. This permits theendoscope to service as a guide for guiding the device 100 through thepatient's throat, down the esophagus, and into the stomach. It alsopermits the gastroesophageal flap valve restoration procedure to beviewed at each stage of the procedure.

As will be seen subsequently, to facilitate shaping of the stomachtissue, the stomach tissue is drawn in between the chassis 104 and thebail 106. Further, to enable a flap of sufficient length to be formed tofunction as the flap of a gastroesophageal flap valve, the stomachtissue is pulled down so that the fold line is substantially juxtaposedto the opening of the esophagus into the stomach. Hence, as will beseen, the stomach is first gripped at a point out and away from theesophagus and the grip point is pulled to almost the hinged connection107 of the chassis 104 and bail 106. As described in copendingapplication Ser. No. 11/001,666, filed Nov. 30, 2004, entitled FLEXIBLETRANSORAL ENDOSCOPIC GASTROESOPHAGEAL FLAP VALVE RESTORATION DEVICE ANDMETHOD, which application is incorporated herein by reference, thedevice 100 is fed down the esophagus with the bail 106 substantially inline with the chassis 104. To negotiate the bend of the throat, and asdescribed in the aforementioned referenced application, the chassis 104and bail 106 are rendered flexible. The chassis 104 is rendered flexibleby the slots 108 and the bail 106 is rendered flexible by the hingedlycoupled links 112. Further details concerning the flexibility of thechassis 104 and the bail 106 may be found in the aforementionedreferenced application.

As further shown in FIG. 3, the device further includes a tissue gripper114. The gripper 114, in this embodiment, comprises a helical coil 115.The coil 115 is carried at the end of a cable 116 and may be attached tothe end of the cable or be formed from the cable. In this embodiment,the helical coil 115 is attached to the cable 116 and is preceded by aguide 118 whose function will be described subsequently.

The helical coil 115 is shown in an approximate position to engage thestomach tissue out and away from the opening of the esophagus to thestomach. The helical coil 115 is guided into position by a guidestructure 120 carried on the bail 106. The guide structure 120 comprisesa guide tube 122. When the device 100 is first introduced down theesophagus into the stomach, the helical coil 115 is caused to residewell within the guide tube 122 to preclude the helical coil fromaccidentally or inadvertently snagging esophageal or stomach tissue.

The guide tube includes a longitudinal slit 126 having a circuitousconfiguration. The slit 126 permits the end of the cable to release ordisassociate from the bail after the stomach tissue is gripped. Thecircuitous configuration of the slit 126 assures confinement of thecable 116 within the guide tube 122 until release of the cable isdesired. The proximal end of the slit 126 has an enlarged portion oropening (not shown). This opening permits the cable and helical coil toreenter the lumen when the device 100 is readied for a repeated stomachtissue shaping procedure. To that end, the guide 118 has a conicalsurface that serves to guide the cable end back into the opening of theslit 126.

With continued reference to FIG. 3, the device 100 further comprises afastener deployer 140. The fastener deployer includes at least onefastener deployment guide 142. The fastener deployment guide 142 takesthe form of a guide lumen. Although only one guide lumen 142 is shown,it will be appreciated that the device 100 may include a plurality ofsuch lumens without departing from the invention. The guide lumenterminates at a delivery point 144 where a fastener is driven into themolded stomach tissue. The fastener deployer may take the form of anyone of the assemblies fully described and claimed, for example, in

The device 100 further includes a window 130 within the chassis 104. Thewindow is formed of a transparent or semi-transparent material. Thispermits gastroesophageal anatomy, and more importantly thegastroesophageal junction (Z-line) to be viewed with the endoscope 110.The window includes a location marker 132 which has a know positionrelative to the fastener delivery point 144. Hence, by aligning themarker with a known anatomical structure, the fastener will be delivereda known distance from or at a location having a predetermined relationto the marker. For example, by aligning the marker with the Z-line, itwill be know that the fastener will be placed aboral of the Z-line andthat serosa tissue will be fastened to serosa tissue. As previouslymentioned, this has many attendant benefits.

It may also be mentioned at this point that the device 100 furtherincludes an invaginator 145 including a plurality of orifices 146. Theseorifices 146, which alternatively may be employed on the longitudinalmember 102, are used to pull a vacuum to cause the device 100 to gripthe inner surface of the esophagus. This will serve to stabilize theesophagus and maintain device positioning during the procedure. Thisvacuum gripping of the esophagus may also be used to particularadvantage if the patient suffers from a hiatal hernia. Upon being thusgripped, the esophagus may be moved downwardly with the device towardthe stomach to eliminate the hiatal hernia.

Now that a device 100 according to the present invention and which maybe used in a method of restoring the flap of a gastroesophageal flapvalve according to this embodiment of the present invention has beendescribed, reference may now be made to FIG. 4. The procedure, accordingto this embodiment, for restoring the flap of the gastroesophageal flapvalve begins with loading a fastener or a plurality of fasteners intothe device 100. As will be seen hereinafter, the fastener deployerincludes a stylet which guides each fastener into the tissue to befastened. The process of loading a fastener, according to thisembodiment, includes snapping a fastener onto the stylet. Arepresentative fastener and stylet will be described subsequently withrespect to FIGS. 14 and 15.

Next, the bail 106 is moved to be substantially in line with the chassis104. Next, the endoscope 110 is inserted into the device with anappropriate lubricant on the endoscope. Next, a bite block, of the typewell known in the art, is inserted into the patient's mouth. A lubricantmay be applied to the device and the device may now be inserted throughthe bite block in the subject's mouth. With the endoscope leading thedevice as illustrated in FIG. 4, the endoscope and device combinationare fed down the esophagus 141 into the stomach. Of course, when theendoscope 110 reaches its fully inserted position, the device 100 may befurther advanced on the endoscope utilizing the endoscope as a guide towithin the stomach of the patient.

As previously mentioned, the device 100 is able to clear the bend in thepatient's throat by virtue of being flexible as previously described.With the endoscope serving as a guide tube, very little force should beneeded to get the device around the neck into the pharynx and down intothe esophagus.

FIG. 5 shows the device 100 upon reaching the interior of the stomach43. Here it may be seen that the bail 106 is substantially in line withthe chassis 104. The endoscope 110 remains within the device 100. Alsoin FIG. 5 it may be noted that the stomach is deflated. This is thenormal condition of the stomach when the stomach is empty.

Once the device is positioned in the stomach as shown in FIG. 5, thestomach is inflated as shown in FIG. 6 by passing air through theendoscope into the stomach. The inflation of the stomach may be noted bythe outward arcuate deflection of the stomach 43. The stomach should beinflated to a first pressure just sufficient to open the stomach andprovide good visibility of gastric folds on the interior wall 59 of thestomach. Visualization of such gastric folds permits discernment of aproper point to grip the stomach for forming the gastroesophageal flapvalve flap in a manner to be described hereinafter. Once the stomach hasbeen inflated to the first pressure, the device is placed in a desiredposition relative to the Z-line by placing the marker of the window 130in a desired position relative to the Z-line 52 marking the transitionfrom the esophagus 41 to the stomach 43. In accordance with thisembodiment, the marker 132 is aligned with the Z-line 52. In order tovisualize the marker and the Z-line, the endoscope 110 is pulled backinto the device 100 and more particular adjacent the marker 132 tovisualize when the marker is aligned with the Z-line 52. With the marker132 aligned with the Z-line 52, the distance from the marker 132 to aproximal point of the elongated member 102 relative to a rather fixedanatomy site of the patient, such as an incisor may be measured. Thismeasurement may be marked on the elongated member 102 and later utilizedfor positioning the marker 132 adjacent the Z-line 52.

Referring now to FIG. 7, with the stomach still inflated to the firstpressure, the endoscope is positioned inside the device just past thehinged connection 107 of the bail 106 and chassis 104. With theendoscope being located just past the hinged connection 107, the bail isthen actuated to an approximally one-half closed position asillustrated. As the bail moves, the bail should be watched to make surethat it moves towards the greater curve 56 so it can move freely in theopen space of the gastric cavity. With the endoscope in the position asshown in FIG. 7, the bail should be visible at all times.

Referring now to FIG. 8, the endoscope 110 is advanced back into thestomach 43 and brought to a reflexed view as illustrated so that it maylook back on the device 100. With the operating end of the device inclear view, the device 100 is positioned in the center of thegastroesophageal flap valve to be formed where the posterior andanterior groove should be. This position is typically opposite thelesser curve 45.

Next, the device positioning relative to the Z-line 52 is checked tomake sure that the marker 132 is in its desired position relative to theZ-line 52. In accordance with this embodiment, the marker 132 is placedadjacent or is aligned with the Z-line 52.

With the device in the correct starting position as shown in FIG. 8, avacuum pump communicating with orifices 146 is energized to pull avacuum through the orifices 146. This causes the orifices to engage thewall of the esophagus 41 for gripping the esophagus. As previouslymentioned, this invagination permits the esophagus to be pushed into thestomach by distal movement of the elongated member 102 to treat a hiatalhernia and to stabilize the position of the device within the stomach.The vacuum is continued to be pulled through the orifices 146 until thevacuum is above the 50 kps mark on the vacuum pump. The device is thenpushed gently aborally to reposition the esophagus to correct a hiatalhernia. It may be noted that this maneuver can also be used to visuallycheck the position of the faster delivery point 144 relative to theZ-line. During this maneuver, the esophagus may roll back on itself andexpose the esophageal Mucosa and the Z-line adjacent to the fastenerdelivery ports.

Referring now to FIG. 9, with the device locked in position by thevacuum orifices 146, the area in which the helical coil is to be engagedmay be identified. The gripping location may be largely determined bythe size or length of the flap to be restored of the restoredgastroesophageal flap valve. This of course may differ from one patientto another depending on the severity of the hiatal hernia and the degreeof valve degradation. Once the gripping location is selected, thestomach 43 is inflated to a second and higher pressure. The inflationpressure of the stomach is increased to the second and higher pressureso that the Mucosa appears tight and the folds essentially flatten. Withthe correct gripping spot identified, the bail 106 is moved to positionthe tip of a helical coil 115 at the correct gripping spot. Next, thedevice 100 is gently pulled upwardly or orally until the bail contactsthe tissue at the desired gripping spot. Next, the helix 115 is advancedby the pushing of the cable 116 until the helix pushes into the Mucosa.Next, the cable 116 is turned to likewise turn the helix 115 in aclockwise direction to screw the helix into the tissue. As the cable isturned, some wind-up may be filled in the helix drive cable.

With the helical coil 115 firmly seated in the tissue, the wind-up inthe cable 116 is released. Referring now to FIG. 10, with the retractorfirmly seated in the tissue, the device 100 may be advanced slightlyorally while at the same time the bail 116 may be opened slightly. Thisreleases the cable 116 from the guide tube which has now been pulledback into the bail 106. The cable 116 exits the guide tube 122 (FIG. 3)by slipping through the circuitous slit 126. This operation is moreparticularly described in the aforementioned U.S. patent applicationSer. No. 11/061,318, filed Feb. 18, 2005, incorporated herein byreference. Also at this time, the correct positioning of the devicerelative to the Z-line may be verified.

With the bail 106 slightly opened and the helix 115 engaged with thetissue 43, the interior of the stomach is now deflated through theendoscope 110. The stomach should be deflated such that the tissueappears loose and collapsed with the Mucosa folds being prominent.However, enough room should be left to view the device.

Referring now to FIG. 11, the gastric tissue is now gently pulled withthe helix 115 and cable 116 towards the hinged connection 107 and thevalve mold to be formed by the chassis 104 and closing bail 106. Oncethe helix is fully retracted into the bail 116, it is locked in place.The bail 106 may now be closed and the device and anatomy will appear asshown in FIG. 12. Here it will be noted that the stomach tissue aboralof the Z-line 52 is confined between the bail 106 and chassis 104 tocreate a fold 150. The fold is also adjacent the fastener delivery point144 at the end of the fastener guide lumen. Since the fastenerdeployment point 144 is a known predetermined distance from the marker132 of the window 130, and since the marker 132 is aligned with theZ-line 52, when a fastener is delivered from the fastener deployer ofthe device, the fastener will exit the fastener delivery point 144 at apoint known to be aboral of the Z-line 52. This assures that only serosatissue is being adhered to serosa tissue in the fixation of the stomachtissue in creating the flap 150. The flap 150 comprises layers 180 and182 of stomach tissue.

With the tissue layers 180 and 182 now disposed within the mold of thechassis 104 and bail 106, the bail 106 may now be locked with respect tothe chassis 104. It is now time to fasten the tissue layers 180 and 182together by ejecting a fastener from the fastener deployer lumen 142 atthe fastener delivery point 144.

Before a fastener is ejected from the fastener deployer lumen 142, thestomach is once again inflated through the endoscope 110. The stomach isinflated to a point where one has a good view of the tissue fold andbail 106.

FIGS. 14 and 15 illustrate a manner in which the device 100 of FIGS.3-13 may deploy a fastener 200 through the layers 180 and 182 of grippedstomach tissue. The fastener 200 generally includes a first member 202,a second member 204, and a connecting member 206. As may be noted inFIG. 15, the first member 202 and second member 204 are substantiallyparallel to each other and substantially perpendicular to the connectingmember 206 which connects the first member 202 to the second member 204.

The first member 202 is generally cylindrical or can any shape. It has achannel 212 that extends therethrough. The though channel 112 isdimensioned to be slidingly received on a tissue piercing deploymentwire 264.

The first member 202 includes a pointed tip 224. The tip 224 may beconical and more particularly takes the shape of a truncated cone. Thetip can also be shaped to have a cutting edge in order to reduce tissueresistance.

The first member 202 also has a continuous lengthwise slit 225. The slit225 includes an optional slot 226 that communicates with the throughchannel 212. The slot 226 has a transverse dimension for more readilyenabling receipt of the tissue piercing deployment wire 264 duringdeployment of the fastener 200. Also, because the fastener member 202 isformed of flexible material, the slit 225 may be made larger throughseparation to allow the deployment wire to be snapped into and releasedfrom the through channel 212.

In addition to the fastener 200 and the deployment wire 264, theassembly shown in FIGS. 14 and 15 further includes a pusher 266 and aguide tube 268. The subassembly of the tissue piercing wire 264,fastener 200, and pusher 266 may be guided to its intended locationrelative to the tissue layers 180 and 182 by the guide tube 268. Thetissue piercing wire 264, fastener 200, and the pusher 266 are allinitially within the guide tube 268. The guide tube 268 isrepresentative of the fastener deployment guide and to that end,includes the fastener deployment guide lumen 142. The subassembly of thetissue piercing wire 264, fastener 200, and pusher 266 may be guided toits intended location relative to the tissue layers 180 and 182 by theguide lumen 142.

As shown in FIGS. 14 and 15, the tissue piercing wire 264 has a tip 270helping it pierce the tissue layers 180 and 182 that will form therestored gastroesophageal flap valve flap 150. The pusher 266 has pushedthe first member 202 of the fastener 200 through the tissue layers 180and 182 on the tissue piercing wire 264. This may be accomplished bymoving the wire 264 and the pusher 266 together.

As may be further noted in FIG. 14, the first member 202 is clearing thewire 264 and tissue layer 182. The tissue piercing wire 264 may now beretracted into the pusher 266 and the tissue piercing wire 264 andpusher 266 may be withdrawn.

FIG. 15 illustrates the fastener 200 in its fully deployed position. Itwill be noted that the fastener has returned to its original shape. Thetissue layers 180 and 182 are fastened together between the first member202 of the fastener 200 and the second member 204 of the fastener 200.The connecting member 206 extends through the tissue layers 180 and 182.

In accordance with a further method of utilizing the fastener deploymentassembly of FIGS. 14 and 15, the tissue piercing wire 264 may be firstadvanced through the tissue layers 180 and 182 by a full stroke and thenlocked. The tip 270 of the deployment wire 264 should extend through thebail 206 with minimal tenting of the tissue. Next, the pusher 266 isadvanced. Visual confirmation that the first fastener member 202 isthrough the tissue is then made. In doing so, the very distal end of thepusher 266 may be visible when the first member 202 of the fastener 200is fully deployed. Next, while holding the pusher 266 at the last notedposition, the tissue piercing wire 264 is retracted. The first member202 of the fastener 200 will fall to the side when the tissue piercingwire 264 reaches the pusher 266. When the tissue piercing wire 264reaches the pusher 266 and after the fastener 200 is deployed, thepusher 266 is pulled back with the tissue piercing wire. If additionalfastener deployment guides are provided, the foregoing steps fordeploying a fastener such as fastener 200 may be repeated.

With the fasteners successfully deployed, the vacuum pull throughorifices 146 may now be turned off to release the device from theesophagus wall as illustrated in FIG. 13. At this time, the bail 106 ofthe device 100 may be slightly opened and the helical coil 115 may bereleased from the stomach tissue. As may be seen in FIG. 13, theprocedure just described results in a flap 150 to be formed. At thistime, an additional fastener or fasteners may be loaded onto the tissuepiercing deployment wire 264 at the proximal end of the longitudinalmember 102.

To render the flap uniform about the opening of the orifice into thestomach, it is necessary at this time to rotate the device 102 andrepeat the previously described procedure for forming a further flapportion. Before this is done, however, it is desirable to position thebail 106 to an almost closed position. Then, the device 100 is movedaborally further into the stomach until the tip end 107 of the bail 106comes to rest on the tip 151 of the newly formed flap portion. This isthe location where the helical coil 115 will next engage the stomachtissue for molding and fixating as previously described.

The foregoing is repeated until a complete valve flap is formed. Whenthe appearance of the valve flap is satisfactory as viewed through theendoscope for visual confirmation, the helical coil 115 is reloaded backinto its original position with the device 100. The vacuum suctionthrough orifices 146 is turned off to release the wall of the esophagusfrom the device. The bail 106 is then moved to a fully opened positionas seen, for example, in FIG. 5. The endoscope may now be retractedalong with the stylet and pusher controls. With the retraction of theforegoing verified, the stomach may now be deflated and the device 100may be removed from the stomach and esophagus. This then completes theprocedure according to this embodiment of the invention.

While particular embodiments of the present invention have been shownand described, modifications may be made, and it is thereto intended inthe appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention.

What is claimed is:
 1. An assembly for restoring a gastroesophageal flapvalve associated with a stomach, comprising: an elongated member havinga distal end for placement in the stomach; a gastroesophageal flap valverestoration device including a chassis and a bail carried at theelongated member distal end, the chassis having a proximal end connectedto the elongated member distal end and a distal end hingedly coupled tothe bail, the bail having an open position for receiving stomach tissueand a closed position for molding the stomach tissue into thegastroesophageal flap valve; a cable extending from a longitudinal slitin the bail, the longitudinal slit permitting the cable to disassociatefrom the bail after stomach tissue is gripped; a coil at the distal endof the cable for engaging stomach tissue so that as the cable is drawninto the chassis the coil pulls stomach tissue into an opening betweenthe bail in the open position and the chassis, the bail is moved to theclosed position toward the chassis to mold stomach tissue there between;the chassis further including a window that permits gastroesophagealanatomy visualization; and the elongated member having vacuum ports fordrawing esophageal tissue tightly against the elongated member to holdthe assembly stationary relative to the esophagus, the vacuum portsbeing positioned on the elongated member proximal of the bail and thecoil.
 2. The apparatus of claim 1, wherein the window is at the proximalend of the chassis.
 3. The apparatus of claim 2, wherein the devicefurther comprises a passage that slidingly receives an endoscopeadjacent the window.
 4. The apparatus of claim 1, wherein the devicefurther includes a fastener deployment guide having a predeterminedorientation relative to the window.
 5. The apparatus of claim 4, whereinthe fastener deployment guide comprises at least one guide lumen.
 6. Theapparatus of claim 1, wherein the window includes a location marker. 7.The apparatus of claim 6, wherein the device further includes a fastenerdeployment guide that guides a fastener into molded tissue.
 8. Theapparatus of claim 7, wherein the deployment guide has a predeterminedorientation relative to the location marker.
 9. The apparatus of claim 6further comprising a fastener deployer that deploys a fastener in moldedtissue at a predetermined location relative to the location marker.